FDA 发布 Q4B 附件 10(R1) 聚丙烯酰胺凝胶电泳通则最终指南
Q4B Annex 10(R1): Polyacrylamide Gel Electrophoresis General Chapter
FDA 发布 Q4B 附件 10(R1) 聚丙烯酰胺凝胶电泳通则最终指南，文件编号 FDA-2009-D-0342。该附件属 Q4B 系列指南之一，由 Q4B 专家工作组评估所选药典文本，供 ICH 区域监管机构作为可互换文本予以认可，以避免行业重复检验。公众可随时就该指南提交意见，书面意见需注明上述文件编号。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2009-D-0342
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
[updated 9/18/2017]
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
Submit Comments
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2009-D-0342.
来源：FDA Pharmaceutical Quality Documents · fda.gov